BACKGROUND AND OBJECTIVES:

Full access to medical care includes cultural and linguistic access as well as financial access. We sought to identify cultural and linguistic characteristics of low-income, ethnic minority patients' recent encounters with health care organizations that impede, and those that increase, health care access.

METHODS:

We conducted four focus groups with ethnically homogeneous African American, Latino, Native American, and Pacific Islander patients. Study participants were "walked" through the stages of a medical encounter and asked to identify physician and staff behaviors that made the patient feel more comfortable (a surrogate for increasing access) and behaviors that made the patient feel less comfortable (a surrogate for decreasing access).

RESULTS:

African American and Native American patients in particular expressed overall satisfaction with their physicians' services. Patients from all groups saw nonphysician staff as frequently impeding access. Based on perceptions of negative stereotypes, Native American and Pacific Islander patients reported hostility toward physicians' efforts at prevention and patient education.

CONCLUSIONS:

For the ethnic minority patients in our study, most perceived that cultural impediments to access involved nonphysician staff. Closer collaborations between health care organizations and ethnic minority communities in the recruitment and training of staff may be needed to improve cultural and linguistic access to care.

Kernicterus, thought to be due to severe hyperbilirubinemia, is an uncommon disorder with tragic consequences, especially when it affects healthy term and near-term infants. Early identification, prevention and treatment of severe hyperbilirubinemia should make kernicterus a preventable disease. However, national epidemiologic data are needed to monitor any preventive strategies. Recommendations are provided to obtain prospective data on the prevalence and incidence of severe hyperbilirubinemia and associate mortality and neurologic injury using standardized definitions, explore the clinical characteristics and root causes of kernicterus in children identified in the Kernicterus Pilot Registry, identify and test an indicator for population surveillance, validating systems-based approaches to the management of newborn jaundice, and explore the feasibility of using biologic or genetic markers to identify infants at risk for hyperbilirubinemia. Increased knowledge about the incidence and consequences of severe hyperbilirubinemia is essential to the planning, implementation and assessment of interventions to ensure that infants discharged as healthy from their birth hospitals have a safer transition to home, avoiding morbidity due to hyperbilirubinemia and other disorders.At a recent NIHCD-sponsored conference, key questions were raised about kernicterus and the need for additional strategies for its prevention. These questions and an approach to their answers form the basis of this report.

Objective: To determine whether health maintenance organizations (HMOs) attract enrollees who use relatively few medical resources and whether a simple risk-adjustment system could mitigate or eliminate the inefficiency associated with risk selection.

Data Sources: The first and second rounds of the Community Tracking Study Household Survey (CTSHS), a national panel data set of households in 60 different markets in the United States.

Study Design: We use regression analysis to examine medical expenditures in the first round of the survey between enrollees who switched plan types (i.e., from a non-HMO plan to an HMO plan, or vice versa) between the first and second rounds of the survey versus enrollees who remained in their original plan. The dependent variable is an enrollee's medical resource use, measured in dollars, and the independent variables include gender, age, self-reported health status, and other demographic variables.

Data Collection Methods: We restrict our analysis to the 6,235 non-elderly persons who were surveyed in both rounds of the CTSHS, received health insurance from their employer or the employer of a household member in both years of the survey, and were offered a choice of an HMO and a non-HMO plan in both years.

Principal Findings: We find that people who switched from a non-HMO to an HMO plan used 11 percent fewer medical services in the period prior to switching than people who remained in a non-HMO plan, and that this relatively low use persisted once they enrolled in an HMO. Furthermore, people who switched from an HMO to a non-HMO plan used 18 percent more medical services in the period prior to switching than those who remained in an HMO plan.

Conclusions: HMOs are experiencing favorable risk selection and would most likely continue to do so even if employers adjusted health plan payments based on enrollees' gender and age because the selection is based on enrollee characteristics that are difficult to observe, such as preferences for medical care and health status.

CONTEXT: Little is known about how the pharmaceutical industry responds to evidence of harm associated with its products, such as the publication in July 2002 of the Women's Health Initiative Estrogen Plus Progestin Trial (WHI E+P) report demonstrating that standard-dose Prempro produced significant harm and lacked net benefits.

OBJECTIVE: To examine pharmaceutical industry response to the WHI E+P results by analyzing promotional expenditures for hormone therapy before and after July 2002.

DESIGN AND SETTING: Nationally representative and prospectively collected longitudinal data (January 2001 through December 2003) on prescribing and promotion of hormone therapies were obtained from IMS Health and Consumer Media Reports.

MAIN OUTCOME MEASURES: Trends in quarterly prescriptions for hormone therapy and expenditures on 5 modes of drug promotion: samples, office-based detailing, hospital-based promotion, journal advertisements, and direct-to-consumer advertising.

RESULTS: Prior to the WHI E+P report, prescribing rates and promotional spending for hormone therapy were stable. In the quarter before the WHI E+P report (April-June 2002), 22.4 million prescriptions for hormone therapy were dispensed and $71 million was spent on promotion (in annual terms, $350 per year per US physician). Within 9 months of the report's publication (quarter 1 of 2003), there was a 32% decrease in hormone therapy prescriptions, and a nadir had been reached for promotional spending (37% decrease compared with pre-WHI E+P levels). Spending decreased for all promotional activities and most hormone therapies. Overall, the greatest declines were for samples (36% decrease as of quarter 1 of 2003) and direct-to-consumer advertising (100% decrease). The greatest declines in promotion occurred for standard-dose Prempro (61% decrease as of quarter 1 of 2003), the agent implicated by the WHI E+P report. More recently, promotional efforts have increased, particularly for lower-dose Prempro, a resurgence associated with modestly increased prescriptions for this newer agent.

CONCLUSIONS: Concordant with its widespread use, hormone therapy was among the most heavily promoted medications prior to the WHI E+P report. Following reporting of the evidence of harm from this trial, there was a substantial decline in promotional spending for hormone therapy, particularly for the agents most directly implicated in the trial. Interrelated with the impact of the trial results themselves and the ensuing media coverage, reduced promotion may have contributed to a substantial decline in hormone therapy prescriptions.

Information technology can support the implementation of clinical research findings in practice settings. Technology can address the quality gap in health care by providing automated decision support to clinicians that integrates guideline knowledge with electronic patient data to present real-time, patient-specific recommendations. However, technical success in implementing decision support systems may not translate directly into system use by clinicians. Successful technology integration into clinical work settings requires explicit attention to the organizational context. We describe the application of a "sociotechnical" approach to integration of ATHENA DSS, a decision support system for the treatment of hypertension, into geographically dispersed primary care clinics. We applied an iterative technical design in response to organizational input and obtained ongoing endorsements of the project by the organization's administrative and clinical leadership. Conscious attention to organizational context at the time of development, deployment, and maintenance of the system was associated with extensive clinician use of the system.

COPYRIGHT RESTRICTION NOTICE:

This material was originally published in the Journal of the American Medical Informatics Association (Volume 11; 368-376). This material may be read on-line or downloaded for personal use only. The material may be referenced by appropriate hyperlinks. However, the text of the material may not be altered without the express permission of the author and AMIA. Care should be taken when excerpting or referencing text to ensure that the views, opinions, and arguments of the author presented in the excerpt accurately reflect those contained in the original work.

This grant does not extend to publication or posting of the paper to any website to which a fee or paid subscription is required to view or otherwise access the work.

Cardiovascular specialists have been leaders in medicine because of our willingness to study major clinical issues by means of randomized clinical trials. Consequently, the evidence supporting many cardiovascular treatments is substantial, especially when the results of multiple large clinical trials are consistent in showing strong benefits. Cardiovascular professional societies also have been at the forefront in forging consensus among clinical experts and codifying best practice into practice guidelines. It is reasonable to expect that a treatment demonstrated to be effective in clinical trials and strongly endorsed by professional guidelines will be adopted by practicing physicians and consistently used in day-to-day patient care.

Angiotensin-converting enzyme (ACE) inhibitors have followed this pathway of building evidence and professional consensus. Many randomized clinical trials have clearly shown that ACE inhibitors reduce mortality and morbidity rates among patients with heart failure and left ventricular systolic dysfunction. Pooled data from 5 large trials showed the odds of death of patients randomized to ACE inhibitors were reduced by 26% compared with placebo, translating into roughly 6 fewer deaths per 100 patients treated. The economic outcomes also are favorable because much of the cost of prescribing ACE inhibitors for heart failure is recouped by the reduced need for hospital admissions. Consequently, the use of ACE inhibitors for heart failure is quite cost-effective. The American College of Cardiology/American Heart Association Guidelines Committee has weighed the evidence and given ACE inhibitors for treatment of heart failure a Class I recommendation. Indeed, use of ACE inhibitors is so well accepted that it is part of the quality-of-care clinical performance measure for heart failure. There is little, if any, controversy that ACE inhibitors should be generally prescribed for patients with heart failure due to systolic dysfunction.

Use of ACE inhibitors increased progressively for heart failure through the early 1990s, but growth in use has stalled more recently, and a substantial number of patients with heart failure still do not receive ACE inhibitors. The data reported by Masoudi and associates in this issue of Circulation show a stubborn, persistent gap between ideal practice and actual use of ACE inhibitors for heart failure. These investigators found that between 1998 and 2001, only 68% of patients 65 years of age and older with heart failure, systolic dysfunction, and no contraindications to treatment received an ACE inhibitor. This percentage rose only to 76% of patients when either ACE inhibitor or angiotensin receptor blocker (ARB) use was counted. The percentage of patients receiving ACE inhibitors or ARBs was below 80% in all but 3 of the 55 subgroups examined by Masoudi and associates. The investigators found little explanation for this persistent and vexing gap between actual and ideal performance, inasmuch as the only strong predictor of ACE inhibitor use versus nonuse was the presence of preexisting renal dysfunction. The latest national report card on this important aspect of heart failure treatment shows a "D+" for ACE inhibitor use (68%), rising only to a "C" (76%) if extra credit is given for ARB use. Should we accept these grades?

Closing the Gap

Perhaps the most optimistic interpretation of the data reported by Masoudi and associates is that evidence from clinical trials, by itself, will only go so far in changing clinical practice. Evidence may be necessary to alter the knowledge and attitudes of physicians about treatment, but this may not be sufficient to change their management consistently. To close the gap between actual and ideal performance, additional, specific measures are probably needed. A variety of active interventions have been shown to improve use of evidence-based therapies. Masoudi and associates did not report any data on use of measures within the hospitals or physician practices that might improve quality of care, so there may be an opportunity to adopt such measures more widely. Reminder systems for physicians, either simple chart-based measures or more sophisticated computerized approaches, can be quite effective in improving use of medications when physicians agree that the medication is effective. Critical pathways, care maps, and other structured approaches to quality improvement also may work well within hospitals to increase adherence to evidence-based practice guidelines. Reorganization of care by use of heart failure care teams or nurse facilitators may be even more effective, but these approaches require a much greater commitment of resources. Nevertheless, multidisciplinary approaches are particularly attractive in the care of patients with chronic diseases such as heart failure, because management of multiple factors, including adherence to diet and medication recommendations, is needed for successful outcomes. The structure of our medical care system also may contribute to the gap between actual and ideal clinical management; paying for innovative practice improvement programs has been difficult because they are not readily reimbursed in the fee-for-service model (although they may be well suited to prepaid integrated healthcare systems).

We have paid a lot of attention to translation of novel therapies from the basic laboratory to proof of efficacy in clinical trials, yet we've not paid enough attention to the final steps of learning how to best deliver consistent, high-quality care. With more attention to the nitty-gritty details of practice improvement, the grade for ACE inhibitor use in patients with heart failure could (and should) be raised to an "A" on the next report card.

This issue of CHP/PCOR's quarterly newsletter covers news and developments from the spring 2004 quarter.

It features articles about: our new core faculty member Paul Wise, a children's health policy researcher who joins us from Boston University; a survey of patient safety culture now getting underway at hospitals nationwide; CHP/PCOR acting director Doug Owens' research findings on the cost-effectiveness of potential HIV vaccines; a wrap-up of the second annual Health Care Quality and Outcomes Research Conference, where CHP/PCOR faculty and trainees attended and presented research; and new CHP/PCOR assistant director Vandana Sundaram.

BACKGROUND: Given the threat of bioterrorism and the increasing availability of electronic data for surveillance, surveillance systems for the early detection of illnesses and syndromes potentially related to bioterrorism have proliferated.

PURPOSE: To critically evaluate the potential utility of existing surveillance systems for illnesses and syndromes related to bioterrorism.

DATA SOURCES: Databases of peer-reviewed articles (for example, MEDLINE for articles published from January 1985 to April 2002) and Web sites of relevant government and nongovernment agencies.

STUDY SELECTION: Reports that described or evaluated systems for collecting, analyzing, or presenting surveillance data for bioterrorism-related illnesses or syndromes.

DATA EXTRACTION: From each included article, the authors abstracted information about the type of surveillance data collected; method of collection, analysis, and presentation of surveillance data; and outcomes of evaluations of the system.

DATA SYNTHESIS: 17 510 article citations and 8088 government and nongovernmental Web sites were reviewed. From these, the authors included 115 systems that collect various surveillance reports, including 9 syndromic surveillance systems, 20 systems collecting bioterrorism detector data, 13 systems collecting influenza-related data, and 23 systems collecting laboratory and antimicrobial resistance data. Only the systems collecting syndromic surveillance data and detection system data were designed, at least in part, for bioterrorism preparedness applications. Syndromic surveillance systems have been deployed for both event-based and continuous bioterrorism surveillance. Few surveillance systems have been comprehensively evaluated. Only 3 systems have had both sensitivity and specificity evaluated.

LIMITATIONS: Data from some existing surveillance systems (particularly those developed by the military) may not be publicly available.

CONCLUSIONS: Few surveillance systems have been specifically designed for collecting and analyzing data for the early detection of a bioterrorist event. Because current evaluations of surveillance systems for detecting bioterrorism and emerging infections are insufficient to characterize the timeliness or sensitivity and specificity, clinical and public health decision making based on these systems may be compromised.

The anthrax attacks of 2001, the outbreak of severe acute respiratory syndrome (SARS), and weapons of mass destruction tabletop exercises have made it clear that no single community can prepare fully, nor respond completely, to a large-scale bioterrorism event. Policymakers recognize the need to forge relationships and coordinate preparedness planning efforts at the local, state, national, and international levels.1 However, there is little consensus about the optimal level of localization or regionalization for each of the resources and services that must be operationalized during a bioterrorism response.

We sought to evaluate the evidence regarding the effectiveness of existing regional systems that facilitate a response to bioterrorism. We sought evidence regarding the tasks that would need to be performed during a bioterrorism response (such as triage, provision of emergency medical care, transportation, and surveillance) and regionalized organizations that would likely contribute personnel, material, and information required to perform these bioterrorism response tasks.

The key questions addressed in this report are:

*What are the key tasks of local responders - such as local public health officials, clinicians, and emergency medical personnel - during a bioterrorism event?

*What resources do local responders require to perform the tasks identified in Key Question 1?

*Which existing regional systems for delivery of goods and services could be relevant to supplying the resources identified in Key Question 2?

*Can regionalization of bioterrorism preparedness planning facilitate supplying needed resources to local responders during a bioterrorism event?

*How do geographic variations in the affected population (e.g., urban as opposed to rural), special populations, and the interplay of private and public sector players affect regionalized systems?